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IRCT20211108052998N1 IRCT 2022-03-09 Fasa University of Medical Sciences The effect of Platelet rich plasma on pregnancy in patients with repeated implantation failure . Comparison of the effectiveness of one time and two times PRP and non-performing PRP in three groups of women with at least two or more pregnancy failures in high-quality embryo transfer who are candidates for embryo freezing in the embryo transfer cycle 2022-03-25 anticipated 180 Complete https://irct.ir/trial/59945 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the three-block randomization method has been used. This study is performed in two hospitals: Hazrat Zeinab and Ghadir mother and child. Randomly and without informing the researcher and the assessment team and only with the knowledge of the clinical caregiver, people in both hospitals were randomized by three-block method and all three patients were divided into control and intervention one and intervention two groups, respectively. The assignment of individuals to study groups will be such that according to the list of attribution codes generated in the random assignment process, one of the three clients will be given a code that indicates which group each person belongs to. Due to the blinding of evaluators and researchers in this method of random allocation, we have tried to reduce the bias in the study to a minimum, Blinding description: The study is double blind and in which patients and researchers do not know the order of random distribution of patients and only the executor knows about it. Blood samples are taken from all patients in the same way to prepare PRP. The patient's field of vision is limited by the barrier between the patient and the clinical caregiver. In the control group, which does not receive any PRP, like other patients, he lies on the bed and in both cases, only an empty catheter without PRP enters the patient's uterine cavity. In the second group, the catheter is emptied for the first time and the catheter containing PRP in the uterine cavity is infused in the second time. In the third group of patients, a catheter containing PRP is infused into the uterine cavity on both occasions. N/A Does not apply. Because this study is not about diseases.. Intervention 1: The first intervention group is the group in which PRP is infused only once for the patient. The initial preparation steps of the control and intervention groups are performed in the same way. For all patients in all three groups, an embryo transfer cycle will be performed by freezing and hormone therapy to prepare the endometrium. For this purpose, estradiol valerate (manufactured by Abu Reihan Company, Tehran, Iran) will be started at a dose of 6 mg on the 3rd day of menstruation and will increase to 8 mg per day if the endometrial thickness does not reach at least 8 mm. During this cycle, when the endometrial thickness is greater than 8 mm, a progesterone suppository (manufactured by Actavis, UK) is started at a dose of 400 mg twice daily for the patient. Quality blastocysts (Grade A or B according to embryological score) will be used for transmission in all patients. All fetal transfers will be performed under ultrasound and by an experienced obstetrician with an infertility fellowship. Embryo transfer is based on the guidelines of the American Reproductive Medicine Association (2 or 3 embryos per patient). Estradiol valerate and progesterone suppositories continue for two weeks after embryo transfer, and if serum β-HCG is positive, these hormones will continue until the 12th week of pregnancy. In this group, PRP infusion is performed only 48 hours before the transfer, and on the 8th day of menstruation, only an empty catheter without PRP enters the uterine cavity. Intervention 2: Intervention group: Intervention group 2. Group in which two PRP infusions are performed on 8 menstrual days and 48 hours before transfer. Intervention 3: Control group: The control group is the group in which an empty catheter enters the uterine cavity on both occasions and no PRP infusion is performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet - the release schedule is still unknown
public Zeinab Shahryari
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3233 2365 Zeinabsh3576@gmail.com Shiraz University of Medical Sciences scientific Zeinab Shahryari
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3233 2365 Zeinabsh3576@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Satisfaction to enter the study Age <40 years Body mass index (BMI) <30 kg / m2 20 years 40 years Female Existence of any uterine abnormalities (congenital or acquired) Existence of any uterine abnormalities (congenital or acquired) Uncontrolled hormonal disease ( prolactinemia or thyroid disease) and endometriosis Blood diseases (hemoglobin <9.0 g / dl and platelet count <100,000 per microliter) Chromosomal defects in the patient or spouse Lack of quality blastocysts (Grade A or B according to embryological score) for transmission Other Other Other The first intervention group is the group in which PRP is infused only once for the patient. The initial preparation steps of the control and intervention groups are performed in the same way. For all patients in all three groups, an embryo transfer cycle will be performed by freezing and hormone therapy to prepare the endometrium. For this purpose, estradiol valerate (manufactured by Abu Reihan Company, Tehran, Iran) will be started at a dose of 6 mg on the 3rd day of menstruation and will increase to 8 mg per day if the endometrial thickness does not reach at least 8 mm. During this cycle, when the endometrial thickness is greater than 8 mm, a progesterone suppository (manufactured by Actavis, UK) is started at a dose of 400 mg twice daily for the patient. Quality blastocysts (Grade A or B according to embryological score) will be used for transmission in all patients. All fetal transfers will be performed under ultrasound and by an experienced obstetrician with an infertility fellowship. Embryo transfer is based on the guidelines of the American Reproductive Medicine Association (2 or 3 embryos per patient). Estradiol valerate and progesterone suppositories continue for two weeks after embryo transfer, and if serum β-HCG is positive, these hormones will continue until the 12th week of pregnancy. In this group, PRP infusion is performed only 48 hours before the transfer, and on the 8th day of menstruation, only an empty catheter without PRP enters the uterine cavity. Intervention group: Intervention group 2. Group in which two PRP infusions are performed on 8 menstrual days and 48 hours before transfer. Control group: The control group is the group in which an empty catheter enters the uterine cavity on both occasions and no PRP infusion is performed. The study has only one outcome and the end result is a pregnancy test. At the end of the cycle, pregnancy is determined by laboratory evaluation of serum β-HCG and the presence of fetal heartbeat on transvaginal ultrasound 2 weeks and 5 weeks after embryo transfer, respectively. Timepoint: evaluation of serum β-HCG and the presence of fetal heartbeat on transvaginal ultrasound 2 weeks and 5 weeks after embryo transfer. Method of measurement: Transvaginal sonography. Shiraz University of Medical Sciences Approved 2021-09-19 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)